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临床试验/CTRI/2024/12/078290
CTRI/2024/12/078290尚未招募不适用

The impact of manual traction physiotherapy technique on The Western Ontario and Mcmaster University Osteoarthritis Index (WOMAC) and CTX-II Levels in patients with Knee Osteoarthritis

Faculty of Medicine Universitas Sumatera Utara1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
37
试验地点
1
主要终点
The main outcomes of this study are the change in the WOMAC score and the levels of CTX-II.

研究概览

简要总结

This study aims to evaluate the effects of a physiotherapy technique known as manual traction on patients with knee osteoarthritis (OA). The focus is on two key outcomes: improvement in knee pain, stiffness, and function, measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and levels of CTX-II, a marker for cartilage breakdown. By comparing these measurements before and after the therapy, the study seeks to determine if manual traction can provide relief and slow cartilage deterioration in knee OA patients

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Men and women over 40 years old.
  • Diagnosed with bilateral knee osteoarthritis (OA) by a qualified doctor.
  • Have not previously received physiotherapy for knee OA.
  • Have a moderate severity of knee OA (Grade 3).
  • Able to answer questions clearly (no cognitive impairments).
  • No other bone or muscle disorders.

排除标准

  • Taking medications like immune system suppressors, corticosteroids, cyclosporins, antipsychotics, or any osteoarthritis drugs, including pain relievers taken by mouth, injection, or applied to the skin (like NSAIDs).
  • Unable to follow the full research protocol.
  • Receiving other medical or traditional treatments for knee osteoarthritis.

结局指标

主要结局

The main outcomes of this study are the change in the WOMAC score and the levels of CTX-II.

时间窗: The main outcome of this study will be assessed at baseline and immediately after the last manual traction session (session 8) in the fourth week.

次要结局

  • The secondary outcome of this research is side effects of manual traction intervention(The side effects of manual traction intervention are assessed 5–15 minutes after each intervention.)

研究者

发起方
Faculty of Medicine Universitas Sumatera Utara
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dedi Ardinata

Department of Physiology, Faculty of Medicine Universitas Sumatera Utara.

研究点 (1)

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